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Enhancing self-management of multimorbidity in primary care

The OPTIMAL study: A randomized controlled trial and process evaluation of an OccuPaTIonal therapy led self MAnagement support programme designed to improve occupational performance and outcomes for patients with muLtimorbidity in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67235963
Enrollment
200
Registered
2013-08-30
Start date
2012-11-29
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity Not Applicable

Interventions

Participants in the intervention group will attend the OPTIMAL programme, a weekly chronic disease self management group facilitated by two primary care occupational therapists. Each session will last
fatigue management
healthy eating
maintaining physical activity (delivered by a community physiotherapist)
maintaining mental health
managing medications (delivered by a pharmacist) and communicating effectively with health professionals. The format of this half of the session will include both group discussion and group activities

Sponsors

HRB Centre for Primary Care Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Exploratory study: 1. Over 18 years of age, both male and female 2. Has a minimum of two chronic conditions 3. Has a minimum of four repeat medication 4. If a primary care clinician identifies they might benefit from the study Follow-up study: 1. Multimorbidity, defined as two or more discrete conditions. This is the internationally accepted definition and encompasses a broad range of patients 2. Age > 40 years. This limit was chosen as multimorbidity is relatively uncommon in patients younger than this and it facilitates targeted recruitment. There is no upper age limit 3. Polypharmacy, defined as four or more repeat medications. This criterion was added in order to identify a group within the broader multimorbidity population that is at increased risk of poor health outcomes and therefore more likely to benefit from an intervention 4. Ability to attend a local community healthcare centre to participate in data collection and the intervention groups

Exclusion criteria

Exclusion criteria: Exploratory study: 1. If unable to travel to centre in which groups were held 2. If person had participated in the feasibility study (O'Toole, Connolly & Smith, 2013) Follow-up study: 1. Psychiatric/psychological morbidity (such as psychosis) or cognitive impairment sufficient to impair participation in the intervention as confirmed by the individual’s GP and/ or practice nurse. 2. Terminal illness likely to lead to death or major disability during the study follow-up period. 3. Inability to attend intervention sessions held outside the home. 4. Participated in the previous pilot studies or exploratory trial.

Design outcomes

Primary

MeasureTime frame
Exploratory study: The Frenchay Activities Index (FAI) is a self-report questionnaire designed to measure participation in social and instrumental activities of daily living. It measures how often the person has engaged in these activities (in the past 3 or 6 months depending on the nature of the activity). The measure contains 15 items divided into three sub scales (domestic chores, leisure work and outdoor activities) with five items in each. Measured at baseline (before programme commenced) and and two weeks post intervention at follow-up. Follow-up study: 1. The EQ-5D (quality of life measure) is a valid and reliable self report questionnaire which measures current health related quality of life (Aggarwal, 2009). It is a two-part measure consisting of a self-reported description (EQ-5D) and self-rated valuation (EQ-VAS). 2. The Frenchay Activities Index (activity participation) is a self report questionnaire designed to measure frequency of participation in social and instrumental activities of daily living and contains 15 items divided into 3 sub scales (domestic chores, leisure work and outdoor activities) with 5 items in each (Miller, Deathe & Harris, 2004). To be measured at baseline (before the programme commences), immediately post-intervention and 6 months post intervention.

Secondary

MeasureTime frame
Exploratory study: 1. The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed for use by occupational therapists to detect change in a client's self-perception of occupational performance over time. The COPM is a standardsed instrument administered in a semi-structured interview format at the beginning and end of OT intervention. Areas assessed using the COPM include the client's most important problems in occupational performance, perceptions of their performance in these activities and their level of satisfaction with their performance. 2. The Nottingham Extended Activity of Daily Living Scale (NEADL) is a self-report scale measuring performance of activities of daily living, comprised of 22 items divided into four sections mobility, kitchen, domestic and leisure. Each item is given one of four responses (able, able with difficulty, able with help, unable) 3. Hospital Anxiety and Depression Scale is a reliable and valid self-assessment scale used to detect and indicate the severity of anxiety and depression in a hospital medical outpatient setting and was utilised in the previous research study. It consists of two subscales, anxiety (HADS-A) and depression (HADS-D) with seven items in each. 4. Stanford Chronic Disease Self-Efficacy Scale (6-item) measures study participants' confidence levels in managing various elements of their chronic diseases such as exercise, social activities, household tasks, medication management and symptom management. 5. EQ-5D (Euroqol) is a valid and reliable self report questionnaire which measures current health related quality of life. The EQ-5D is a self report questionnaire for describing and valuing health-related quality of life (Aggarwal, 2009). It is a two-part measure consisting of a self-reported description (EQ-5D) and a self-rated valuation (EQ-VAS). The self reported description (EQ-5D) comprises five

Countries

Ireland

Contacts

Public ContactLynn O' Toole
otoolely@tcd.ie+35 (0)3 864002582 /+35 (0)3 8963220

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026